Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic (Coco)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by HiPP GmbH & Co.
Sponsor:
Information provided by (Responsible Party):
HiPP GmbH & Co.
ClinicalTrials.gov Identifier:
NCT01721850
First received: October 30, 2012
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.

Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.


Condition Intervention
Infantile Colic
Other: control formula
Other: intervention formula 1
Other: intervention formula 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study

Resource links provided by NLM:


Further study details as provided by HiPP GmbH & Co.:

Primary Outcome Measures:
  • daily total crying time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group


Secondary Outcome Measures:
  • growth parameters [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    determination of body weight, lenght, head circumference

  • tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomitting, diarrhea, skin reactions

  • formula intake [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    evaluation of average daily drinking amount and formula acceptance

  • intestinal microbiota [ Time Frame: 0-28 days ] [ Designated as safety issue: No ]
    evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention


Estimated Enrollment: 174
Study Start Date: December 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control formula
infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol
Other: control formula
commercial stage 1 infant formula
Experimental: intervention formula 1 group
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Other: intervention formula 1
infant formula with hydrolyzed protein (type I) and pre- and probiotics
Experimental: intervention formula 2 group
infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol
Other: intervention formula 2
infant formula with hydrolyzed protein (type II) and pre- and probiotics

  Eligibility

Ages Eligible for Study:   up to 50 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy term infants
  • Subjects appropriate for gestational age between 37 and 41 weeks
  • Subjects between 15-50 days old
  • Subjects with birth weight between 2500 and 4000 g and regular weight gain (≥150g / week)
  • Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
  • Subjects exclusively bottle-fed at study entrance
  • Day care of the child only by mother/father
  • Provide written informed consent in accordance with legal requirement

Exclusion Criteria:

  • Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
  • Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
  • Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
  • Subjects receiving formula for special medical purposes
  • Exclusively breast-fed infants
  • Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion
  • Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
  • Participation in any other clinical intervention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721850

Contacts
Contact: Claudia Steiner, Dr 00498441757523 Claudia.Steiner@hipp.de

Locations
Italy
Pediatric office Recruiting
Carmagnola, Piemonte, Italy, 10022
Contact: Pietro Lerro, Dr.         
Pediatric office Recruiting
Grugliasco, Piemonte, Italy, 10095
Contact: Amalia Peltran, Dr.         
Pediatric office Recruiting
Racconigi, Piemonte, Italy, 12035
Contact: Martina Costamagna, Dr.         
Pediatric office Recruiting
Rivoli, Piemonte, Italy, 10090
Contact: Eleonora Bruno, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10124
Contact: Monica M Bianco, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10148
Contact: Emanuela Malorgio, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10147
Contact: Marco Fonsati, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10126
Contact: Massimo Landi, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10126
Contact: Anna M Liatti, Dr.         
Pediatric office Recruiting
Torino, Piemonte, Italy, 10141
Contact: Elena Tempesta, Dr.         
Pediatric office Recruiting
Venaria, Piemonte, Italy, 10078
Contact: Filomena C Martino, Dr.         
Sponsors and Collaborators
HiPP GmbH & Co.
Investigators
Principal Investigator: Francesco Savino, Dr. Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
  More Information

No publications provided

Responsible Party: HiPP GmbH & Co.
ClinicalTrials.gov Identifier: NCT01721850     History of Changes
Other Study ID Numbers: HiPP-505092
Study First Received: October 30, 2012
Last Updated: November 2, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by HiPP GmbH & Co.:
infant nutrition, infantile colic

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 18, 2014